Regulatory Affairs Manager – Oncology Submissions

ORIC Pharmaceuticals Inc.; San Diego (CA); On-site; USD 145,000 - 165,000; Full time

Job summary

ORIC Pharmaceuticals Inc. is seeking an experienced Regulatory Affairs professional to advance oncology product development. You will collaborate across regulatory operations, quality, CMC, and clinical teams to ensure high-quality, timely submissions.

The ideal candidate has 6–8 years of regulatory affairs experience, strong writing skills, and a proactive, cross-functional mindset to balance strategy with execution. This on-site role is based in San Diego with competitive salary and benefits.

Qualifications

• Bachelor’s degree in science or related field; advanced degree preferred.
• 6–8 years of regulatory affairs experience in pharma/biotech.
• Experience preparing regulatory submissions (IND, DSUR, CTA, FDA meetings).
• Strong communication and collaboration skills across stakeholders.
• Excellent writing and editorial skills for clinical-regulatory documents.

Responsibilities

• Support regulatory submissions and contribute to program strategy.
• Prepare and deliver high quality, timely regulatory submissions.
• Create, assemble, review, and archive complex submissions with CROs.
• Develop, manage and track submission timelines.
• Collaborate cross-functionally with regulatory ops, quality, CMC, nonclinical, and clinical teams.
• Ensure accuracy, completeness and consistency of submissions, maintain archives.
• Review investigator packages and support site start-up from regulatory perspective.
• Analyze regulatory issues and communicate intelligence internally.
• Contribute to SOP development to ensure regulatory compliance.

Skills

Regulatory submissions

Cross-functional collaboration

Project management

Regulatory intelligence

Excellent written communication

Education

Bachelor’s degree in a scientific or related field

Advanced degree preferred

Tools

Veeva RIM

Microsoft Office Suite

Job description

ORIC Pharmaceuticals Inc. is seeking an experienced Regulatory Affairs professional to advance oncology product development. You will collaborate across regulatory operations, quality, CMC, and clinical teams to ensure high-quality, timely submissions.

The ideal candidate has 6–8 years of regulatory affairs experience, strong writing skills, and a proactive, cross-functional mindset to balance strategy with execution. This on-site role is based in San Diego with competitive salary and benefits.